Events

Recall of SSP UNITRAY - HIGH RESOLUTION CLASS II

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFE TECHNOLOGIES CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80620
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    One complaint regarding this issue has been received. complaint states the dpb1 ssp unitray kit has a false negative in lanes 27 30 and 39 which gives no perfect match typing result for the dpb1*53:01 allele. internal investigation has confirmed with the now available rare sample type that lanes 27 30 and 39 are negative for the dpb1*53:01 allele in the above listed affected kits according to the labeling provided with the kits. however the primer mixes in lanes 27 30 and 39 are functioning as originally intended. the primer mixes within lanes 27 30 and 39 target regions of the dpb1*53:01 allele which are undefined.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 451606D (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 451616D (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 54070D (Lot serial: 008 1127336)
  • Product Description
    DPB1 SSP UniTray Kits (with our without Taq Polymerase)
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION